Med Prep Consulting Inc., a New Jersey compounding pharmacy, is temporarily closed after mold was found in bags of its injection drugs. Contaminated drug lawyers at Pintas & Mullins Law Firm remind the public that the recent fungal meningitis outbreak, which has killed nearly 50 people so far, was caused by mold contamination.
The compounding pharmacy recalled all lots of its products currently in circulation, and has agreed to cease manufacturing and shipping until at least March 22, 2013. The recall will affects thousands of syringes, bags, and vials of premixed solutions at hospitals throughout the country.
The New Jersey Health Commissioner stated that the investigation into Med Prep is ongoing, and recommends that any health care facility that received products from the New Jersey pharmacy should inventory them and return them to the pharmacy immediately.
According to NBC News, at least 13 hospitals in New Jersey, Connecticut, Delaware and Pennsylvania are known to have received 50-ML bags of magnesium sulfate solution from Med Prep, which is a commonly-used electrolyte replacement product. The pharmacy’s plastic syringes were also shipped to doctor’s offices and clinics across the country.
The initial contamination was reported by a Connecticut hospital, at which officials identified visible floating particles of mold in the drugs. Mold was confirmed in five bags of vital injection drugs at the hospital. Fortunately, no patients have yet fallen ill from the contaminated drugs, which were distributed between February 18 and March 13, although officials note that they do not know how many patients could have received the drugs already.
The investigation into Med Prep is being conducted by officials from the FDA and the New Jersey Pharmacy Board. Med Prep will undoubtedly be under much more increased scrutiny for this mold contamination after the fatal outbreak at the New England Compounding Pharmacy in 2012.
Just six months ago, that compounding pharmacy released contaminated epidural painkillers to healthcare facilities throughout the country. This fungal meningitis outbreak sickened more than 700 patients and killed 50. As a result of this occurrence, Congress and other powers called for an overhaul in the oversight and regulation of American compounding pharmacies.
The FDA previously warned the president of Med Prep twice, in 2001 and 2010, about its concerns about the sterility of the company’s repackaged drugs. Other possibly contaminated products include labor and delivery pain medications, antibiotics, local and general anesthetics, and cardiac pain drugs.
Since the investigation is ongoing, officials are not yet sure where the contamination occurred, as Med Prep uses ingredients from numerous large suppliers. The investigation into the New England Compounding Pharmacy is currently evolving as well, and the incubation period for this outbreak is unknown, as patients continue to be infected more than six months after the first outbreaks.
The New England Compounding Pharmacy filed for bankruptcy in December 2012,
promising to establish a fund to compensate victims of the outbreak. The
pharmacy is currently facing more than 400 lawsuits in connection to the
fungal meningitis-infected steroids. NECC officials stated that the bankruptcy
was in effort to provide a fairer and faster payout to victims
Unlike major drug manufacturers, such as Pfizer or Bayer, the operations at compounding pharmacies are not as strongly regulated as the public may assume. Compounding pharmacies are intended to mix medications (not approved by the FDA) on a patient-by-patient basis, for those who require more specialized medications. Some are saying the contaminations were a calamity waiting to happen.
Doctors are urging patients who may have been exposed to the mold contamination to contact a healthcare provider quickly if they experience any symptoms like fever, dizziness, severe headache, loss of balance, or slurred speech.
Dangerous drug lawyers at Pintas & Mullins Law Firm are concerned about the risks compounding pharmacies like NECC and Med Prep pose to public health. These most recent outbreaks are not the first incidents of deadly contamination coming from compounding pharmacies. Similar outbreaks took place in 2002 and 2011, in South Carolina and Alabama, respectively. If you or a loved one was infected with an illness from a contaminated drug, you have important legal rights, and may be entitled to significant compensation.